Total Fem Bal

Total Fem Bal
SPL v2
SPL
SPL Set ID 0f61111c-5472-45bf-8ce7-a7c4d12fc21b
Route
ORAL
Published
Effective Date 2019-08-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (10 [hp_X]) Cholesterol Estrone Bos Taurus Hypothalamus Sus Scrofa Ovary Anemone Pulsatilla
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-01

Description

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 5.55 mL each in 10X, 30X, and LM1 potencies: Adrenalinum, Cholesterinum, Folliculinum, Hypothalamus, Oophorinum, Pulsatilla. *The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

WARNINGS:

Stop use and call a doctor if symptoms

persist or worsen.

If pregnant or breast-feeding, consult

a healthcare professional before use.

Keep out of reach of children.

Contains alcohol: in case of accidental

overdose, consult a poison control center

immediately.

Indications and Usage

INDICATIONS: For the temporary relief of

hormonal imbalances associated with

premenstrual syndrome, irregular

menstrual cycle, water retention, mild

depression, irritability and moodiness. (**)

Dosage and Administration

DIRECTIONS: Take 6 drops orally 4 times

a day. For ages 12 to adult.

Description

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 5.55 mL each in 10X, 30X, and LM1 potencies: Adrenalinum, Cholesterinum, Folliculinum, Hypothalamus, Oophorinum, Pulsatilla. *The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 51727-6

INACTIVE INGREDIENTS: Ethanol (20%

v/v), Purified water.

Section 51945-4

NDC 61657-2971-1

MICRO-WEST

Homeopathic

TOTAL 

FEM-BAL

Product #: 0971

1.0 fl oz (29.6 mL)

Ethanol 20%

Section 55105-1

For the temporary relief of

hormonal imbalances associated with

premenstrual syndrome, irregular

menstrual cycle, water retention, mild

depression, irritability and moodiness. (**)

Section 55106-9

ACTIVE INGREDIENTS (HPUS*): 100 mL

contains 5.55 mL each in 10X, 30X, and

LM1 potencies: Adrenalinum, Cholesterinum,

Folliculinum, Hypothalamus, Oophorinum,

Pulsatilla. *The letters “HPUS” indicate

that the components in the product are

officially monographed in the Homeopathic

Pharmacopeia of the United States.

Section 60561-8

OTHER INFORMATION: Tamper resistant

for your protection. Use only if safety seal

is intact. (**) Claims based on traditional

homeopathic practice, not accepted

medical evidence. Not FDA evaluated


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS: For the temporary relief of

hormonal imbalances associated with

premenstrual syndrome, irregular

menstrual cycle, water retention, mild

depression, irritability and moodiness. (**)

Dosage and Administration (34068-7)

DIRECTIONS: Take 6 drops orally 4 times

a day. For ages 12 to adult.

Warnings and Precautions (34071-1)

WARNINGS:

Stop use and call a doctor if symptoms

persist or worsen.

If pregnant or breast-feeding, consult

a healthcare professional before use.

Keep out of reach of children.

Contains alcohol: in case of accidental

overdose, consult a poison control center

immediately.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol (20%

v/v), Purified water.

Section 51945-4 (51945-4)

NDC 61657-2971-1

MICRO-WEST

Homeopathic

TOTAL 

FEM-BAL

Product #: 0971

1.0 fl oz (29.6 mL)

Ethanol 20%

Section 55105-1 (55105-1)

For the temporary relief of

hormonal imbalances associated with

premenstrual syndrome, irregular

menstrual cycle, water retention, mild

depression, irritability and moodiness. (**)

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*): 100 mL

contains 5.55 mL each in 10X, 30X, and

LM1 potencies: Adrenalinum, Cholesterinum,

Folliculinum, Hypothalamus, Oophorinum,

Pulsatilla. *The letters “HPUS” indicate

that the components in the product are

officially monographed in the Homeopathic

Pharmacopeia of the United States.

Section 60561-8 (60561-8)

OTHER INFORMATION: Tamper resistant

for your protection. Use only if safety seal

is intact. (**) Claims based on traditional

homeopathic practice, not accepted

medical evidence. Not FDA evaluated


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)